EUCTR2013-001650-94-GB
Active, not recruiting
Phase 1
An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
ConditionsPremature EjaculationMedDRA version: 14.1 Level: PT Classification code 10036596 Term: Premature ejaculation System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
DrugsBOTOX®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Premature Ejaculation
- Sponsor
- Allergan Limited
- Enrollment
- 59
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· written informed consent has been obtained from both the patient and his female partner
- •· male aged 18 to 50 years
- •· in a stable monogamous sexual relationship with a female partner for at least 6 months (with the
- •intention to continue with the same partner for the duration of the study)
- •· diagnosed with lifelong PE (defined as symptoms starting at the time the patient became sexually
- •· meets PE criteria (based on the 2008 International Society of Sexual Medicine \[ISSM] definition)
- •· previously tried at least one form of therapy for PE (eg, behavioral therapy, topical therapy, or oral
- •therapy) but patient remains dissatisfied
- •· mean screening intravaginal ejaculatory latency time (IELT) of \= 1 minute (calculated from the 4 most
- •recent evaluable events recorded on the screening sexual event log \[SEL])
Exclusion Criteria
- •· any medical or surgical condition that could be associated with secondary (acquired) PE or patient has
- •PE which is situational or attributable to relationship issues
- •· a score of \< 25 on the International Index of Erectile Function \- Erectile Dysfunction (IIEF\-ED)
- •questionnaire at screening
- •· patient is unable or unwilling to discontinue (ie, washout) prohibited medications from at least 28 days
- •prior to efficacy measurements, and throughout the duration of the study. Prohibited medications
- •1\) dapoxetine (Priligy™, Kutub™) or any other medications with selective serotonin reuptake
- •inhibitor (SSRI) activity
- •2\) tramadol or any other medications with serotonin norepinephrine reuptake inhibitor (SNRI)
- •activity or with opiate activity
Outcomes
Primary Outcomes
Not specified
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